The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.
Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major muscular troubles such as spasticity. This spasticity may induce pain, loss in range of motion and permanent joint deformities. The aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50 with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter). Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
Centre Hospitalier Neurologique William Lennox
Ottignies, Brabant Wallon, Belgium
Change in the Modified Ashworth Scale
Spasticity assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Modified Tardieu Scale
Spasticity assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Nociception Coma Scale-Revised
Pain assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Visual Analogue Scale
Pain assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Palm-finger distance
Range of motion assessment
Time frame: Week 0, 1, 3, 4, 6, 12
Change in the Coma Recovery Scale-Revised
Consciousness assessment
Time frame: Week 0, 1, 3, 4, 6, 12
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